To compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.
Primary Endpoint: Overall Survival Secondary Endpoints: Time Frame: Up to 45 months; Progression-free survival (PFS), Objective response rate (ORR,) Disease-control rate (DCR), Duration of response (DOR), safety and tolerability
The FGFR inhibitor trials are all being conducted in patients with FGFR alterations and locally advanced UC and the preliminary data presented at ASCO in at least one inhibitor is very encouraging. It will be interesting to see how an FGFR inhibitor performs in the first line setting in patients with an alteration when compared to standard chemotherapy or immunotherapy. Upper tract urothelial cancer (UTUC)